Why Are Regulatory Requirements a Major Impediment to Genetic Engineering of Horticultural Crops? - Transgenic Horticultural Crops: Challenges and Opportunities - page 252

about.regulatory.reforms 3,4 .and.taking.part.in.national.and.international.workshops.
designed.to.inform.or.inluence.regulations, 5 .have.shown.me.how.important.they.are..
I.now.often.argue.that.every.plant.scientist.who.works.in.and.understands.the.poten-
tial.beneits.of.transgenic.plant.biotechnology.needs.to.understand.regulations,.and.
play.a.role.in.improving.them..The.goal.is.to.craft.regulations.that.more.effectively.
target.and.limit.very.high.risk.applications,.while.minimizing.encumbrances.to.ield.
research.on.safe.and.highly.valuable.applications..At.least.for.now,.regulations.and.
their.implementation.are.still.evolving,.providing.an.opportunity.for.inluence.from.
scientists. 6 . In. addition,. all. applications. for. permits. and. petitions. for. deregulation.
(USDA). and. registration. of. GE. pest-tolerant. plants. (EPA). have. required. periods.
of open.public.comment;.the.high.quality.science-based.or.data-based.input.that.is.
often.received.from.biotechnology.scientists.is.valued.by.regulatory.agencies.
CONSEQUENCES OF FAILURE TO COMPLY
WITH REGULATIONS ARE LARGE
Regulations.are.informed.by.science,.but.mainly.they.embody.the.overall.“attitude”.of.
a.society.about.a.technology. 7 .Emotions,.perceptions,.economics,.and.politics.generally.
dwarf.the.inluence.of.science.in.developing.regulatory.policies..Regulations.can.be.writ-
ten.with.a.tone.of.aversion.and.extreme.caution.when.society.senses.risk.and.harm.rather.
than.direct.beneit—as.we.see.today.with.plant.biotechnology..Or,.they.can.be.written.
with.a.sense.of.optimism.and.encouragement,.as.we.tend.to.see.today.with.respect.to.
wind.power.and.related.technologies..Because.regulations.have.the.force.of.law.behind.
them,. even. minor. violations. can. have. signiicant. penalties. including. heavy. ines. and.
even.imprisonment..Thus,.they.have.a.power.and.gravity.very.different.from.research.
procedures.or.recommendations,.such.as.those.followed.in.molecular.biology.laborato-
ries.in.the.United.States.under.the.National.Institute.of.Health.(NIH).recombinant.DNA.
research.guidelines..The.risks.and.costs.of.complying.with.regulations—or.being.unable.
to.comply—often.determine,.not.just.inform,.scientiic.and.business.strategies.
As.seen.with.the.StarLink.GE.maize.debacle 8 .and.with.the.ongoing.multimillion.
dollar.lawsuits.over.accidental.infusion.of.USDA-approved.GE.rice.that.harmed.U.S..
exports, 9 .the.consequences.of.getting.the.regulations.about.gene.dispersal.(often.called.
adventitious.presence.[AP].or.low-level.presence.[LLP]).wrong,.even.in.small.detail,.
can.be.enormous.for.companies.and.for.the.entire.agricultural.sector..In.addition,.recent.
successful. lawsuits. over. USDA.decisions. on.herbicide.resistant.sugar. beets,.alfalfa,.
and.creeping.bentgrass.have.set.new.precedents.for.use.of.the.National.Environmental.
Protection. Act.. Its. requirement. for. Environmental. Impact. Statements. in. regulatory.
decisions.on.crop.biotechnologies.has.brought.the.courts.into.the.regulation.of.crop.
biotechnology. in. a. major. way 10 . that. requires. far. more. work. and. legal. detail. to. the.
process.in.order.to.increase.the.likelihood.that.Animal.and.Plant.Health.Inspection.
Service.(APHIS).decisions.can.withstand.legal.challenges..In.addition,.given.the.broad.
interpretation. of. what. National. Environmental. Policy. Act. (NEPA). covers. in. these.
cases—which.include.economic.damages.to.organic.and.conventional.farmers.from.
AP—it.is.unclear.whether.the.preparation.of.Environmental.Impact.Statement.(EISs).
will.improve.the.quality.of.scientiic.analysis.of.the.underlying.biological.issues.